Senior Director of Quality Compliance

Compensation:
Approximately $180,000-$220,000 base salary + bonus potential

A growing pharmaceutical manufacturing organization is seeking a Sr. Director of Quality Compliance to lead enterprise-wide compliance strategy, governance, audit readiness, inspection management, escalation processes, and quality risk management activities. This individual will serve as a key member of the Quality Leadership team and will drive continuous improvement initiatives to ensure sustained compliance with cGMP, FDA, DEA, DSCSA, and international regulatory requirements.

This role will oversee quality compliance systems and inspection readiness programs while partnering cross-functionally with Quality, Manufacturing, Regulatory, Supply Chain, and Executive Leadership teams. The ideal candidate will bring deep expertise in pharmaceutical quality systems, regulatory inspections, auditing, and enterprise compliance strategy within GMP-regulated manufacturing environments.

• Develop and implement enterprise quality compliance strategies, programs, and policies
• Ensure compliance with FDA, DEA, cGMP, ICH, DSCSA, and global regulatory requirements
• Lead inspection readiness programs and provide on-site support during regulatory inspections
• Serve as the primary escalation point for significant quality and compliance risks
• Manage quality notification-to-management and escalation programs
• Interpret evolving regulatory requirements and implement systemic compliance improvements

• Direct internal audit programs across manufacturing and quality operations
• Lead and manage external audits conducted by FDA, DEA, notified bodies, clients, and global health authorities
• Review audit observations and drive effective CAPA implementation
• Maintain audit-ready quality systems and documentation practices
• Track and trend quality indicators and compliance metrics

• Oversee core Quality Management System (QMS) processes including:
• Change control
• Deviations
• CAPAs
• Document management
• Analyze quality data and trends to identify systemic risks and improvement opportunities
• Ensure effective statistical monitoring and reporting of quality compliance metrics
• Support post-market surveillance and ongoing product quality monitoring activities

• Lead and develop Quality Compliance teams and associated quality personnel
• Partner with Manufacturing, Quality Control, Regulatory Affairs, and Executive Leadership to drive strategic quality initiatives
• Foster a culture of compliance, accountability, and continuous improvement
• Support implementation of quality-focused operational efficiencies and business improvements
• Present quality compliance updates and risk assessments to senior leadership

• Drive initiatives focused on improving inspection outcomes, audit performance, and overall quality culture
• Lead implementation of systemic process improvements across manufacturing and quality operations
• Evaluate and enhance quality systems effectiveness through analytics and risk management principles
• Support modernization initiatives involving predictive analytics, technology platforms, and quality data visibility

• Bachelor’s degree in Pharmacy, Chemistry, Biology, Chemical Engineering, or related scientific discipline
• 15+ years of progressive pharmaceutical quality experience within GMP-regulated manufacturing environments
• Prior senior leadership experience in Quality Compliance, Quality Assurance, or Regulatory Compliance
• Strong experience interacting directly with FDA and global regulatory agencies

• Deep knowledge of:
• cGMP regulations
• FDA and global regulatory requirements
• DEA compliance
• Quality systems and auditing
• Pharmaceutical manufacturing operations
• Experience supporting API, aseptic, sterile, or OTC manufacturing environments preferred
• Strong understanding of:
• Deviations
• CAPAs
• Change controls
• Inspection readiness
• Supplier quality management
• Data integrity

• Travel up to approximately 40% may be required
• Relocation assistance may be available
• Experience with in pharmaceutical manufacturing, CDMO, or highly regulated GMP environments strongly preferred